Chiral Separation Methods for Pharmaceutical and Biotechnological Products

Discusses chiral separations and offers guidance for selecting the optimum method for desired results Chiral separations represent the most intriguing and, by some measures, most difficultseparations of chemical compounds. This book provides researchers and students an under-standing of chiral separations and offers a convenient route to selecting the best separation method, saving considerable time and cost in product development. Considering chiral separations in the biotechnological and pharmaceutical industries, as well as for food applications, Dr. Ahuja provides insights into a broad range of topics. Opening with a broad overview of chiral separations, regulatory considerations in drug product development, and basic issues in method development, the book: Covers a variety of modern methods such as gas chromatography, high performance liquid chromatography, supercritical fluid chromatography, and capillary electrophoresis Deals with the impact of chirality on the biological activity of small and large molecules Provides detailed information on useful chiral stationary phases (CSPs) for HPLC Includes handy information on selection of an appropriate CSP, including mechanistic studies Offers strategies for fast method development with HPLC, SFC, and CE Discusses preparatory methods utilized in the pharmaceutical industry With in-depth discussions of the current state of the field as well as suggestions to assist future developments, Chiral Separation Methods for Pharmaceutical and Biotechnological Products is an essential text for laboratory investigators, managers, and regulators who are involved in chiral separations in the pharmaceutical industry, as well as students preparing for careers in these fields.

Discusses chiral separations and offers guidance for selectingthe optimum method for desired resultsChiral separations represent the most intriguing and, by somemeasures, most difficultseparations of chemical compounds. Thisbook provides researchers and students an under-standing of chiralseparations and offers a convenient route to selecting the bestseparation method, saving considerable time and cost in productdevelopment.Considering chiral separations in the biotechnological andpharmaceutical industries, as well as for food applications, Dr.Ahuja provides insights into a broad range of topics. Opening witha broad overview of chiral separations, regulatory considerationsin drug product development, and basic issues in methoddevelopment, the book:* Covers a variety of modern methods such as gas chromatographyhigh performance liquid chromatography, supercritical fluidchromatography, and capillary electrophoresis* Deals with the impact of chirality on the biological activity ofsmall and large molecules* Provides detailed information on useful chiral stationary phases(CSPs) for HPLC* Includes handy information on selection of an appropriate CSPincluding mechanistic studies* Offers strategies for fast method development with HPLC, SFCand CE* Discusses preparatory methods utilized in the pharmaceuticalindustryWith in-depth discussions of the current state of the field aswell as suggestions to assist future developments, ChiralSeparation Methods for Pharmaceutical and BiotechnologicalProducts is an essential text for laboratory investigatorsmanagers, and regulators who are involved in chiral separations inthe pharmaceutical industry, as well as students preparing forcareers in these fields.

Contributors.Preface.1 Overview of Chiral Separations (SatinderAhuja).2 Regulatory & Development Considerations of ChiralCompounds (Robert L. Zeid).3 Basic Considerations in Method Development for ChiralCompounds (Satinder Ahuja).4 Separations of Chiral Compounds on PolysaccharideColumns (Clinton W. Amoss and Norbert M. Maier).5 Chiral Separations by Various Techniques (Jian G.Ning).6 Chiral Discrimination Study for Polysaccharide Based ChiralStationary Phase (Yun K. Ye).7 Comparison of Chiral Chromatographic Columns forPharmaceuticals (Gregory K. Webster).8 Chiral Separation Screens for Pharmaceutical Analysis andPurification in an Industrial Laboratory Environment (RobertDePianta, Kenneth Douville, Beverly Nickerson, and Ricardo E.Borjas).9 The Separation of Enantiomers by Gas Chromatography onChiral Stationary Phases (Volker Schurig).10 Separations of Chiral Compounds by SFC (ZiqiangWang).11 Chiral Separations by Capillary Electrophoresis(Debby Mangelings and Yvan Vander Heyden).12 High-Throughput Screening and Method-DevelopmentStrategies to Separate Chiral Drug Compounds in HPLC, SFC, andCE (Hasret Ates, Debby Mangelings and Yvan VanderHeyden).13 Use of Enantioselective Synthesis and Preparative ChiralChromatography to Access a Challenging Enantiopure PharmaceuticalCandidate from a Mixture of Four Stereoisomers (ChristopherJ. Welch, Derek H. Henderson, William R. Leonard, Mirlinda BibaMike Zacuto, Fred Fleitz, Amude Kassim, Cheng-yi Chen, and PeterSajonz).14 A Look into the Future: Chiral Analysis Using ChemicalSensor Technology (Gregory K. Webster and William J.Buttner).15 Chirality of Biomolecules and Biotechnology Products(Satinder Ahuja).Index.